Medication info
Simroks EF Tablet

Simroks EF Tablet

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
A white to off-white, biconvex, rectangular tablet
Packaging
30 tablets ((10 tablets/PTP)x3)
Approval status
Active

MFDS item code 201601084 · Approved 2016.02.26 · Insurance code 621802810

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg daily, with a generally recommended initial dose of 10/20mg daily. If there is a low necessity to reduce LDL cholesterol, it may be started at 10/10mg daily. After starting the administration or adjusting the dosage, blood lipid levels should be checked at intervals of more than 4 weeks.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
  • hypothyroidism
  • obstructive liver disease
  • chronic renal failure
View approved original text

This medicine helps lower elevated total cholesterol, LDL cholesterol, ApoB protein, and triglycerides, and increase HDL cholesterol in patients with primary hypercholesterolemia, especially in heterozygous familial and non-familial mixed hyperlipidemia. It is also used as an adjunctive treatment for homozygous familial hypercholesterolemia patients when other treatments are not effective, and to reduce the risk of atherosclerotic vascular disease. This drug is administered in conjunction with an appropriate dietary regimen and is generally given when other non-drug treatments are insufficient. Before treatment, secondary causes such as diabetes mellitus and hypothyroidism must be identified and treated if necessary, and the treatment effect should be monitored through regular lipid tests. Early lipid testing and appropriate treatment are also recommended in cases of acute coronary events. This drug is effectively used to improve hypercholesterolemia.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg daily, with a generally recommended initial dose of 10/20mg daily. If there is a low necessity to reduce LDL cholesterol, it may be started at 10/10mg daily. After starting the administration or adjusting the dosage, blood lipid levels should be checked at intervals of more than 4 weeks.

Precautions

This drug may cause muscle-related side effects such as myopathy or rhabdomyolysis, so if you experience muscle pain or weakness while taking it, you should inform your doctor immediately. Patients with allergies to this drug's components or those with impaired liver function, as well as women who are pregnant or breastfeeding, should not take this medication. In particular, those with liver disease or patients with abnormally high liver enzyme levels in blood tests should not be administered this drug, and liver function tests should be performed regularly during treatment. This drug may interact with certain medications, for example, potent CYP3A4 inhibitors, fibrates, some antibiotics, and antifungal agents can increase the risk of myopathy, so you must inform your physician or pharmacist about any medications you are taking. Special caution is required for the elderly, women, patients with hypothyroidism, and those with impaired kidney function, as the risk of muscle side effects is higher in these groups. Women planning to become pregnant should consult their doctor before taking this drug, and should immediately discontinue use if pregnancy is confirmed. Breastfeeding women should stop breastfeeding when taking this drug, and safety and efficacy in children and adolescents have not been fully established, thus caution is needed. If unexplained muscle pain, weakness, or changes in urine color occur while taking this drug, you should promptly consult healthcare professionals. In case of overdose, since there is no specific antidote, appropriate treatment should be received based on symptoms, and when starting or stopping other medications while taking this drug, it must be done according to medical instructions.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, hepatitis, pancreatitis, liver failure, skin-mucous membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme, drug-induced liver injury, myopathy, rhabdomyolysis, severe edema, severe muscle weakness, ocular myasthenia, liver abnormalities (jaundice), severe allergic reactions, serious skin adverse reactions, respiratory issues, severe neurological symptoms, significantly decreased urine output, increased blood pressure

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • nausea
  • constipation
Show 20 more
  • dyspepsia
  • rash
  • itching
  • weakness
  • sensory disturbances
  • dizziness
  • insomnia
  • gastritis
  • atrophic gastritis
  • mucous stools
  • irritable bowel syndrome
  • sore throat
  • nocturia
  • hematuria
  • alopecia
  • decreased libido
  • sexual dysfunction
  • anemia
  • weight loss
  • increased serum creatine kinase

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. In addition, it is best to store the medication at room temperature between 1°C and 30°C, avoiding areas that are too hot or too cold.

Appearance and packaging

Appearance

A white to off-white, biconvex, rectangular tablet

Package unit

30 tablets ((10 tablets/PTP)x3)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.